Dept of Anaesthesiology, Trelleborg Hospital
Trelleborg, Sweden
NCT Number: NCT06230081
The purpose of this study is to evaluate the effect on postoperative pain, opioid consumption and function by adding a combination of regional blocks with local anaesthetic before total hip- and knee arthroplasty compared to standard pain management strategies.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Trelleborg, Sweden
400 patients with osteoarthritis of the knee (200) or hip (200) necessitating total hip- or knee replacement are entered into the study. All patients are given a standard protocol of analgesics pre- and postoperatively. Patients are receiving general- or spinal anaesthesia during the surgery. General anaesthesia is conducted using Remifentanil 50ug/ml and Propofol 20 mg/ml utilizing a TCI protocol. The airway is managed by LMA or endotracheal tube. Spinal anaesthesia is conducted using isobaric Bupivacaine (hip) and hyperbaric bupivacaine (knee). Decision regarding type of anaesthesia is following guidelines of our department taking contraindications and patients preference into account.
Patients randomized to the block-group undergoing hip replacement surgery with posterior approach are given och combination of PENG block and Iliohypogastric block using Ropivacain 5 mg/ml with a total dose of 200 mg along with clonidine in a total dose of 75 micrograms. Patients undergoing hip replacement with lateral approach are given a combination of PENG block and LFCN block using Ropivacain 5 mg/ml with a total dose of 125 mg along with clonidine in a total dose of 56,25 micrograms. Patients randomized to the standard pain management strategy undergoing hip replacement surgery are given a combination of opioids, paracetamol and Cox-II inhibitors.
Patients randomized to the block-group undergoing knee replacement surgery are given a combination of iPACK-, genicular-, AFCN-, adductor canal and vastus intermedius block using Ropivacain 5 mg/ml with a total dose of 225 mg along with clonidine in a total dose of 75 micrograms. Patients randomized to the standard pain management strategy undergoing knee replacement surgery are given a perioperative periarticular LIA using Ropivacaine 300 mg along with 0,5 mg of adrenaline.
The randomization is executed on the day before surgery by opening of a closed numbered envelope giving information if the specific patient should have a block (intervention) or not (control). There are 200 prepared envelopes for the hip replacements and 200 for the knee replacements, with 100 blocks and 100 no blocks for each type. The envelopes are prepared by block randomization performed by computer software. Nurses and physiotherapists who evaluate postoperative pain are blinded from the intervention. The physician compiling the data from the study is also blinded to the intervention.
Preoperatively, information is collected regarding doses of analgesics and pain in everyday life is evaluated using the NRS scale. Preoperative pain is evaluated at rest and during mobilization.
Postoperatively, an evaluation of pain is made. After the operation the patients are monitored at the ward by the nurses and physiotherapists. The registration takes place using the subjective Numeric Rating Scale (NRS) and the objective Critical-Care Pain Observation Tool (CPOT). Pain is continuously evaluated during the hospital stay. The final registration takes place at the return visit 14 days after surgery. During the hospital stay, other parameters such as opioid consumption, requirement for urinary catheter, postoperative nausea and vomiting (PONV), time to mobilization and neurological complications are also registered. The number of extra opioid doses the patient requires are also registered. The number of days the patients need to stay in hospital after surgery are registered.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug used in the block
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Patient experienced postop pain assessed by NRS (0-10)
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Difference in extra oral- and intravenous analgesia consumption (tablets or injections - in mg)
Time frame: The day of surgery, postop day 1
Difference in time mobilizing to standing after surgery
Time frame: The day of surgery, postop day 1
Difference in postoperative nausea and vomiting (reported frequency)
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Difference in postoperative pain depending on method of anesthesia, i.e. General- or Spinal anesthesia. Assessed by NRS (0-10)
Time frame: 1-5 days post-surgery
Difference in frequency of urine catheter usage
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Difference in frequency of neurological complications (reported to and assessed by physiotherapist)
Time frame: 1-5 days post-surgery
Number of postoperative days in hospital
Time frame: 14 days post-surgery
Difference in opioid consumption 14 days after surgery
Region Skane
Other
Postoperative Analgesia in Patients Undergoing Hip and Knee Replacement Surgery - a Study Comparing Ultrasound-guided Nerve Blocks With Intraoperative Local Anesthetic Infiltration or Opioids
Acronym: BLAST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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